SAN FRANCISCO - Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage biopharmaceutical company, announced today that its oral small molecule therapeutic, GSBR-1290, showed statistically significant weight loss in two separate studies.
The Phase 2a obesity study and a capsule to tablet pharmacokinetic (PK) study both met their primary and secondary objectives, with participants achieving an average weight loss of 6.2% and up to 6.9%, respectively, at 12 weeks.
In the Phase 2a study, 67% of participants treated with GSBR-1290 experienced at least 6% weight reduction, while 33% saw a decrease of 10% or more, compared to no significant weight loss in the placebo group. The trials also reported favorable safety and tolerability outcomes, with gastrointestinal side effects being the most common adverse events, which diminished after dose titration.
GSBR-1290, a glucagon-like-peptide-1 (GLP-1) receptor agonist, is part of Structure's efforts to create oral treatments for metabolic and cardiopulmonary diseases. The company's CEO, Dr. Raymond Stevens, highlighted the potential for GSBR-1290 to become a leading therapy for obesity and related conditions. The drug's once-daily dosing and pharmacokinetic profile support its use as a convenient and effective treatment option.
The upcoming Phase 2b study, slated to begin in the fourth quarter of 2024, will further evaluate GSBR-1290's efficacy and safety in a larger population over 36 weeks. This global trial will involve approximately 300 participants and will utilize the tablet formulation of the drug.
Ania Jastreboff, M.D., Ph.D., of Yale School of Medicine, underscored the need for accessible oral treatments for obesity, a condition projected to affect 1 billion people globally by 2030. GSBR-1290's promising Phase 2 results indicate its potential as a future therapeutic option.
Structure Therapeutics plans to submit an Investigational New Drug (IND) application to the FDA in the third quarter of 2024, with the aim of initiating the Phase 2b obesity study. The company will host a conference call today at 8:30 a.m. ET to discuss these findings.
The information in this article is based on a press release statement from Structure Therapeutics Inc.
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